MR850 MR850AEURecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 09420012407207), received between Dec 19, 2019 and Oct 1, 2024 — classified as 1 death, 6 malfunctions.

The most frequently reported specific device problem is “No Audible Alarm” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2024No Audible Alarm; No Audible Alarm

  A DISTRIBUTOR IN INDIA REPORTED THAT AN MR850 RESPIRATORY HUMIDIFIER WAS FAULTY. UPON DEVICE SERVICING AT THE REGIONAL OFFICE IN INDIA, IT WAS DISCOVERED THAT THE AUDIBLE ALARM WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20348374 ↗
• MalfunctionJun 12, 2024No Audible Alarm; No Audible Alarm

  A DISTRIBUTOR IN SOUTH AFRICA REPORTED THAT THE AUDIBLE ALARM OF A MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19525358 ↗
• MalfunctionApr 4, 2024No Audible Alarm; Mechanical Problem; No Audible Alarm; Mechanical Problem

  A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE AUDIBLE ALARM OF A MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19048111 ↗
• MalfunctionNov 7, 2023Fire; Fire

  A DISTRIBUTOR IN INDIA REPORTED, VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, AN INCIDENT IN WHICH A FIRE OCCURRED WHEN SETTING UP A BUBBLE CPAP SYSTEM. THE HEALTHCARE FACILITY REPORTED TO F&P HEALTHCARE THAT THE BUBBLE CPAP SYSTEM WAS BEING SET UP IN PREPARATION FOR PATIENT USE HOWEVER THE DEVICES WERE NOT IN USE ON A PATIENT NOR CONNECTED TO A PATIENT AT THE TIME OF THE REPORTED EVENT. THE SYSTEM INCLUDED AN F&P HEALTHCARE MR850 RESPIRATORY HUMIDIFIER THAT WAS BEING USED WITH A F&P HEALTHCARE TEMPERATURE PROBE AND A NON-F&P HEALTHCARE HEATERWIRE ADAPTOR (MANUFACTURER UNKNOWN). THE HEALTHCARE FACILITY ALSO REPORTED THAT THE F&P HEALTHCARE BC161 BUBBLE CPAP SYSTEM HAD BEEN RE-USED FOR APPROXIMATELY ONE YEAR AND HAD BEEN USED ON MULTIPLE PATIENTS DURING THIS TIME. THE HEALTHCARE FACILITY REPORTED THAT, FOLLOWING SET UP OF THE DEVICES AND PRIOR TO PATIENT USE, THE MR850 RESPIRATORY HUMIDIFIER WAS POWERED ON AND HEATING, AND THE OXYGEN WAS CONNECTED WITH A FLOW RATE OF 5L/MIN. WITHIN APPROXIMATELY 10 MINUTES THE HUMIDIFICATION CHAMBER, WHICH IS PROVIDED AS PART OF THE BC161 BUBBLE CPAP SYSTEM, WAS OBSERVED TO BE ON FIRE. THERE WAS NO PATIENT INVOLVEMENT OR USER INJURIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18089290 ↗
• MalfunctionNov 30, 2022No Audible Alarm; No Audible Alarm

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN THAILAND VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE AUDIBLE ALARM OF A MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15891580 ↗
• MalfunctionSep 4, 2022No Audible Alarm; No Audible Alarm

  A DISTRIBUTOR IN THAILAND REPORTED THAT THE AUDIBLE ALARM OF A MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353698 ↗
• DeathDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISTRIBUTOR ON BEHALF OF A HEALTHCARE FACILITY IN (B)(4) REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT A PRE-TERM INFANT DECEASED WHILST ON AN MR850 RESPIRATORY HUMIDIFIER (HUMIDIFIER) ALONG WITH A VENTILATOR. THE INFANT, WHO HAD A LOW BIRTH WEIGHT, 1.8 KG, WAS SUFFERING FROM RESPIRATORY DISTRESS SYNDROME DUE TO HYALINE MEMBRANE DISEASE FOR WHICH HE RECEIVED SURFACTANT AND VENTILATION. IT WAS REPORTED THAT THE HUMIDIFIER WAS DISPLAYING THE TEMPERATURE OF 40.1 DEGREES AND IT WAS NOT ALARMING AT THAT TIME. IT WAS REPORTED THAT THE INFANT SUFFERED A SUDDEN TACHYCARDIA AND HAD A READING OF AXILLARY TEMPERATURE (USING AN EXTERNAL THERMOMETER) GREATER THAN 42.9 DEGREES CELSIUS. EMERGENCY CORRECTIVE TREATMENT WAS PERFORMED INCLUDING CHANGING THE HUMIDIFIER AND THE INFANT'S TEMPERATURES GRADUALLY CORRECTED THEREAFTER. HOWEVER, THE INFANT RAPIDLY BECAME UNSTABLE AND DETERIORATED WHICH TRIGGERED THE MEDICAL INTERVENTION THAT INCLUDED VENTILATION, INOTROPIC SUPPORT AND AN EMERGENCY BLOOD TRANSFUSION AS A RESPONSE TO A PULMONARY HEMORRHAGE THAT WAS DEVELOPED IN THE INFANT. DESPITE RESUSCITATION ATTEMPTS, THE INFANT DETERIORATED AND DECEASED.

  Patient problems: Death

  MAUDE report 9494376 ↗